Monday, January 26, 2009

University of Wisconsin + Wyeth = Biased CME

In the fall of 2002, the Women’s Health Initiative stopped its NIH-funded clinical trial of hormone replacement therapy, because women randomized to receive hormone therapy (estrogen + progesterone) had more breast cancer, heart disease, and strokes than those not taking the drugs.

This presented Wyeth, the manufacturer of the implicated drug Prempro, with a problem: a potentially catastrophic loss of income.

They responded the way drug companies generally respond when their product is shown to be hazardous. They ramped up their marketing. They criticized the methods of the study. They emphasized the need to weigh risks vs. benefits.

And, according to this riveting article from the Milwaukee Journal Sentinel, Wyeth deployed an army of ghostwriters and academics to create a one-sided $12 million CME program which is under investigation by the Senate Finance Committee.

According to the article, Wyeth hired a marketing communications company called DesignWritewhich teamed up with UW Medical School to create an organization they named “The Council on Hormone Education.” This council was composed of 40 academics in the field, 34 of whom had ties financial ties to Wyeth.

It is unclear if the members of the council actually created any course content or if they simply were paid to put their names on CME articles written by DesignWrite ghostwriters. At any rate, the council stamped its name on 16 CME newsletters, the stated goals of which were "to develop and disseminate balanced, accurate, timely and consistent information about hormone therapy" so doctors could "better serve women."The newsletters included articles such as "A Perspective on WHI (the Women's Health Initiative)," "Choosing the Right Therapy for Postmenopausal Osteoporosis" and "Sexual Desire Disorder in the Postmenopausal Woman."

Sounds pretty academic.

But when John Fauber and Susanne Rust, the investigative reporters, showed the materials to independent experts in the field, here were the reviews:--Jacques Rossouw, chief of the Women's Health Initiative branch of the National Institutes of Health said, according to the paper, that “the views expressed in the course are not those of the general scientific community and are not suitable for a university medical education course.” "There is a history of this kind of thing from Wyeth," Rossouw said. "The materials regurgitate lines that I have heard and read many times, and I have come to believe (though I do not know) that this is part of an overall marketing strategy to the profession. It is not good science because it fails to strive for any kind of balance."

--Raymond Gibbons, a professor of medicine at the Mayo Clinic and former president of the American Heart Association, “said he also found material relating to heart disease one-sided. He noted that the materials inappropriately gave observational data equal weight to rigorously done, randomized clinical trials. ‘It's a lot of post hoc analysis,’ he said. ‘I don't see the other side of the argument.’"

-- Marcia Stefanick, an investigator with the Women's Health Initiative, told the Journal Sentinel that “since the results of the first large clinical trial on hormone therapy were released in 1998, drug companies have been trying to minimize the concerns….They are very eager to keep coming up with ways to show it isn't harmful….There is this constant attempt to get women back into it."

--Anthony Scialli, an adjunct professor of obstetrics and gynecology at Georgetown University's School of Medicine, put it simply: "It is pure, undisguised marketing.”

And what is the University of Wisconsin, the ACCME-accredited sponsor of the program, saying and doing? First, they immediately pulled the program from their website after the Journal Sentinel started asking inconvenient questions. Second, an apparently very embarrassed George Mejicano, who is director of UW’s CME programs, is not giving the straightest of answers. For example, when asked if the course had received criticism, he is quoted as answering: “Yes and no. It’s complicated.”

It’s not really so complicated. UW took in $1.5 million from Wyeth to help them advertise Prempro in the guise of CME. Money clarifies the mind and sharpens incentives.

Meanwhile, UW is involved in several other ongoing big ticket CME initiatives. These include:

--Boehringer Ingelheim’s program on restless leg syndrome . The company happens to make Mirapex, a drug for RLS.

-- Bayer HealthCare Pharmaceutical’s courseon premenstrual dysphoric disorder. Bayer happens to make Yasmin, an oral contraceptive being touted as a good treatment for…yes, premenstrual dysphoric disorder.If you want to enjoy these advertisements, you’d better get on it. I’ll wager that the chastened university will be soon be shutting down these websites as well!

5 comments:

therapyfirst
said...

Nice reporting. By the way, I was told the following article is not yet on the site, www.rollingstone.com, but I hope any and all interested readers hunt it down via internet or newstand:Ben Wallace-Wells, entitled Bitter Pill, is a 10 page expose about Lilly, Zyprexa, and antipsyhotics in general, and it does not speak positively about them.

My interest was mostly in the last page, regarding Ralph Aquila, a schizophrenia specialist from Columbia University, who works at the Fountain House. He goes on to note the psychosocial role in working with these patients has an appreciable effect with meds. DUH!

I hope the proverbial anchor that is atypical antipsychotics drags down all idiots who write for these meds like pez. Because, now that the lawsuits are peaking and will be winding down in the nearer than later future, physicians will be legitimately accountable for writing for these scripts from hereon.

Let's see if the ego of Astra Zeneca can be reeled in before they disastorously pursue anxiolytic indications further with Seroquel. Or, anchors away!!

Maybe one solution is to stop having insurance companies pay for prescriptions. Then there would be less of a market for these meds. Of course then my patients with RA who can't afford drugs like Humira would be in bad shape.

Or, banning direct to consumer marketing. I have a patient who has done well on a combination of generic antidepressants and therapy. She doesn't like having to change her lifestyle in a way that will prevent her depression. So, her solution? Pristiq!!! She saw lots of ads on how it works well and doesn't have side effects (she couldn't tolerate Effexor XR because of nausea). I spent most of a session explaining that her depression goes into full remission if she uses her Wellbutrin and Celexa and maintains a healthy lifestyle. I don't think I convinced her and am quite sure she will find someone to give her Pristiq. I told her that given her response to Effexor I was not going to prescribe that and did not base my medical judgment on TV ads. But what chance does logical thought have in the face of a multi-million dollar marketing campaign.

If there weren't the ads and if she had to pay for Pristiq herself then it would have been a different story. She did show some reluctance to the idea of Pristiq when I told her that since she had done well on other antidepressants I would have to put that on a PAR and her insurance company would not be likely to approve it.

Is there a solution? I don't know. I have to keep reminding myself "Speak the truth, but give up attachment to results"

I know this is a CME blog, but when one marketing path is blocked, what you get are other 'creative interventions', such as this upcoming webcast on "priming the pre-visit patient", a fancy way of saying "convincing patients to demand specific branded medications":

But here's the problem. My physician parses the research well enough to come to her own conclusions: no hormones for her patients.

For others with less-savvy docs, does this make it a pharma-marketing problem or a doctor-education problem?

When medical schools start weeding out students whose biggest asset is a photographic memory, then maybe we'll have more physicians who provide an scientifically rigorous bulwark against pharma phooey.

For those of us in the CME world AND with a concern for quality education and patient care, these issues force us to spend priceless resources to show ACCME we are not of this ilk before we even think of developing a worthwhile CME activity. Meanwhile, those with massive resources can afford to break all the rules and force ACCME chase them down, which they seldom do. And when caught, there are little or no sanctions.

For the record, pharmaceutical companies do not "sponsor" accredited medical education, but rather buy their way onto the planning committee's with "educational grants" to influence the CME content. This too is against the rules but it happens everyday. Only ACCME accredited CME providers may "sponsor" accredited continuing medical education. As I said, just for the record.